A substantial portion of medications are not taken as prescribed. By some estimates, in clinical practice up to 50% or more of medications either may not be taken at all or may be taken with significant deviations from what is prescribed for the patient. For example, doses of a medication may be skipped, the medication may not be taken at the right intervals, at the right times, in the right dose, applied in the correct manner, etc. Such deviation from a prescribed medication regimen may be referred to broadly as “nonadherence”. Nonadherence to prescribed medication regimens may have dramatic negative effects on health and/or healthcare costs, whether considering individuals or societies collectively.
Nonadherence may be even more common in clinical research, wherein some estimates indicate nonadherence of up to 70% or more. Nonadherence in a research context also presents other potential concerns. For example, testing of new medications typically may include efforts to determine the effectiveness of the medication, what side effects occur, how severe those side effects may be, in what fraction of the population those side effects occur, etc. Thus nonadherence in a research setting may distort the basic understanding of a medication, e.g., if a medication is in fact highly effective if taken as prescribed but ineffective or dangerous if not taken properly, poor adherence within a clinical trial may result in data showing that the medication is not effective (when the actual problem is that it was not taken correctly).
One matter complicating issues related to nonadherence is that reliable data on the existence, degree, and form(s) of nonadherence present may be difficult to acquire. Whether for an individual, a larger population, or even a carefully selected and/or monitored group such as the subjects in a clinical trial, authentic data on how much nonadherence is taking place, among whom, and in what forms (e.g., missing doses, taking the medication incorrectly, etc.) may not be available through conventional sources. Typically, key information on adherence may be obtained by requiring deliberate action by the user, e.g., patients and/or test subjects may record and then report when a medication is taken, in what does, etc. However, patients and/or test subjects may not reliably perform such deliberate actions as recording or reporting medication use. Put bluntly, if individuals do not reliably take a medication, record and reports regarding the taking of that medication also may be unreliable. Thus, in practice it may not even be known how much nonadherence is taking place (beyond estimates), much less what the specific impacts of nonadherence may be in a given case, without authenticated data.
In addition, while at least in principle certain aspects of recording and/or reporting may be actively reported by an autonomous system, e.g., by incorporating electronic sensors into a medication container and storing or transmitting the data acquired, this too may present challenges in at least certain circumstances. For example, sensors typically require electrical power, and thus failing to charge or replace a battery may render such a system inoperable. Likewise, sensors and other electronics may be susceptible to damage from conditions as may be common to a medication container that is handled and/or carried regularly, e.g., the container may get wet, be dropped, be sat upon (for example if kept in a pocket), be exposed to extreme temperatures (for example if left in a car on a hot day or kept in an outer coat pocket in very cold weather), be bumped or compressed by other objects in a pocket or bag, etc. Damage from such conditions also may render an electronic system inoperable.